EVO756 / Evommune, Maruho - LARVOL DELTA

Beyond Omalizumab: Emerging Biologic and Small Molecule Therapies in Chronic Spontaneous Urticaria. (PubMed, Clin Exp Allergy) - "The oral BTK inhibitor remibrutinib is now licensed for adults in the United States and European Union; Dupilumab, approved from 12 years of age in 2025, was extended to children aged 2-11 years in 2026 on basis of extrapolated efficacy supported by paediatric pharmacokinetic and safety data. Barzolvolimab has completed Phase 3 enrolment of 1939 adults, briquilimab, EVO756, EP262 and rilzabrutinib are advancing in adults and ligelizumab failed to demonstrate superiority over omalizumab...Adults dominate the trial populations; adolescents are enrolled as underpowered subgroups; dedicated paediatric evidence is essentially confined to dupilumab; and older adults-in whom comorbidity, polypharmacy and the cardiovascular and malignancy signals of JAK inhibition matter most-are almost never analyzed separately. Head-to-head and sequencing trials, endotype-stratified patient selection, age-inclusive trial design and long-term safety data are the immediate priorities if..."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Oncology • Pediatrics • Urticaria • IL13 • IL4

Evommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Atopic Dermatitis (Businesswire) - "The Phase 2b trial enrolled 121 adults with moderate-to-severe AD over a 12-week treatment period, with follow-up through Week 14, and did not meet the primary and secondary endpoints in any of the doses studied. Based on these results, the Company does not plan to advance EVO756 in AD....Trial did not meet the primary endpoint of percent change in Eczema Area and Severity Index (EASI) score from baseline at Week 12; EVO756 was generally well tolerated."

Discontinued • P2b data • Atopic Dermatitis

Evommune to continue Phase 2b development of EVO756 in migraine prophylaxis (Businesswire)

Clinical • Migraine

Prioritization of EVO756 Development Outside of CSU (Businesswire) - "The study did not meet the primary endpoint...Following these results, Evommune has discontinued development of EVO756 in CSU..."

Discontinued • Trial status • Chronic Spontaneous Urticaria • Immunology

EVO756 – Oral MRGPRX2 Antagonist Program (Businesswire) - "The Company expects to report top-line data in September 2026 for the fully-enrolled Phase 2b dose-ranging clinical trial (N=120) in moderate-to-severe AD patients."

P2b data • Atopic Dermatitis

Migraine Prophylaxis Phase 2b Trial Now Underway with Top-Line Data Anticipated in 2027 (Businesswire) - "The trial is evaluating EVO756 in adults with refractory migraine experiencing ≥6 migraine days per month. Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment."

P2b data • Migraine

Evommune…announced the first patient was dosed in its Phase 2b clinical trial evaluating a potent, highly selective oral small molecule antagonist of MRGPRX2, EVO756, for the prophylactic treatment of migraine (Businesswire) - "The Phase 2b trial is a global, randomized, double-blind, placebo-controlled, dose-ranging study evaluating EVO756 in adults with refractory migraine experiencing ≥6 migraine days per month. Approximately 330 patients will be randomized across two active dose arms and placebo for 12 weeks of treatment....Top-line data expected in 2027."

P2b data • Trial status • Migraine

Evommune Announces Top-line Results from EVO756 Phase 2b Trial in Moderate-to-Severe Chronic Spontaneous Urticaria (Businesswire) - "The Phase 2b trial enrolled 160 moderate-to-severe antihistamine-refractory CSU patients in the United States, Europe, Canada and Japan. Participants received one of three active dose regimens or placebo. The study did not meet the primary endpoint of mean change in a patient’s Urticaria Activity Score over seven days (UAS7) at 12 weeks at any dose....'We remain on track to report top-line Phase 2b data for EVO756 in atopic dermatitis (AD) in the third quarter of 2026.'"

P2b data • Trial status • Atopic Dermatitis • Chronic Spontaneous Urticaria • Immunology

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU) (clinicaltrials.gov) - P2 | N=182 | Completed | Sponsor: Evommune, Inc. | Active, not recruiting ➔ Completed

Trial completion • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Study of EVO756 in Adults With Migraine (clinicaltrials.gov) - P2 | N=330 | Recruiting | Sponsor: Evommune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Migraine

EVO756 – Oral MRGPRX2 Antagonist Program (Yahoo Finance UK) - "Enrollment is complete in a Phase 2b dose-ranging clinical trial (N=160) in moderate-to-severe CSU and the Company expects to report top-line results in June 2026...Enrollment is complete in a Phase 2b dose-ranging clinical trial (N=120) in moderate-to-severe AD patients and the Company expects to report top-line results in the third quarter of 2026."

Enrollment closed • P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria

Targeting MRGPRX2 Addresses Unmet Need in Atopic Dermatitis: An in Silico Network Analysis (FOCIS 2026) - "This signature was integrated into the CytoReason AD in silico disease model—a comprehensive computational representation of disease biology that integrates 24 RNAseq datasets, >2,000 human skin samples including clinical EASI scores and dupilumab response data. These data position MRGPRX2 as a critical pathway in AD, which persists despite standard-of-care biologics treatment. Targeting MRGPRX2 via oral inhibitors like EVO756 offers a compelling strategy to address the significant unmet need in both Type 2-high and Type 2-low AD populations."

Atopic Dermatitis • Dermatitis • Immunology • IL13 • IL4

Study of EVO756 in Adults With Migraine (clinicaltrials.gov) - P2 | N=330 | Not yet recruiting | Sponsor: Evommune, Inc.

New P2 trial • CNS Disorders • Migraine • Pain

Phase 2b Study of EVO756 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Evommune, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Highlighted Role of MRGPRX2 in Migraine and Planned Phase 2b Development Program (Yahoo Finance UK) - "The Company recently hosted a virtual event, alongside key opinion leaders, overviewing the role of MRGPRX2 in migraine and its plans to initiate a Phase 2b dose-ranging clinical trial in migraine prophylaxis in mid-2026. Top-line data from the trial are anticipated in 2027...The Company will also present a poster highlighting the pivotal role of MRGPRX2 impacting both meningeal mast cells and trigeminal neurons in migraine pathophysiology at the American Headache Society (AHS) Annual Scientific Meeting being held June 4-7, 2026 in Orlando, FL."

New P2b trial • Preclinical • Migraine

New Translational Data to be Presented at Two Upcoming Scientific Conferences (Yahoo Finance UK) - "At the Federation of Clinical Immunology Societies (FOCIS) Annual Meeting, being held June 9-12, 2026 in San Francisco, CA, Evommune will present two posters: the first highlighting shared pathology data in chronic inducible urticaria (CIndU) and CSU patient samples, and the second providing an comprehensive and unprecedented in silico assessment of patient samples identifying MRGPRX2 as a persistent driver of disease in AD."

Clinical • Atopic Dermatitis • Chronic Spontaneous Urticaria • Urticaria

Phase 2b Study of EVO756 in Adults With Moderate to Severe Chronic Spontaneous Urticaria (CSU) (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Evommune, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

…Upcoming Milestones: EVO756 - Oral MRGPRX2 Antagonist Program (Businesswire) - "(i) A Phase 2b dose-ranging trial (N=160) in moderate-to-severe CSU was initiated in April 2025, and the Company expects to report top-line results in the second quarter of 2026; (ii) The Company also initiated a Phase 2b dose-ranging trial (N=120) in moderate-to-severe AD patients in August 2025 and expects to report top-line results in the second half of 2026...; (iii) The Company plans to initiate a Phase 2b trial in migraine in mid-2026..."

New P2b trial • P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria • Migraine

Pipeline Highlights: EVO756 (Businesswire) - "A Phase 2b dose-ranging trial (n=160) in moderate-to-severe CSU was initiated in April 2025, and the Company expects to report top-line results in the first half of 2026. The Company also initiated a Phase 2b dose-ranging trial (n=120) in moderate-to-severe atopic dermatitis (AD) patients in August 2025 and expects to report top-line results in the second half of 2026."

P2b data • Atopic Dermatitis • Chronic Spontaneous Urticaria

Targeting MRGPRX2: A Transformative Approach to Inflammatory Skin Conditions (ISDS 2025) - "Clinically, oral EVO756 suppressed icatibant-induced wheal formation in a phase 1 trial, confirming its ability to inhibit MRGPRX2-mediated responses in humans. These findings establish MRGPRX2 as a master regulator of mast cell and sensory neuron activation, driving neurogenic inflammation in CSU, AD, and beyond. EVO756 offers a potential groundbreaking therapeutic strategy, delivering multipronged benefits by targeting key pathogenic pathways across inflammatory skin diseases and other chronic inflammatory conditions."

Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Immunology • Inflammation • Urticaria • IL33

EVO756, an Oral MRGPRX2 Inhibitor, Demonstrates Robust Treatment Effect in Chronic Inducible Urticaria (EADV 2025) - "All TEAEs were nonserious and none led to discontinuation of treatment. Overall, EVO756 was well tolerated."

Late-breaking abstract • Atopic Dermatitis • Chronic Spontaneous Urticaria • Dermatitis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Pruritus • Urticaria

Evommune Presents Full Phase 2 Data for Oral MRGPRX2 Inhibitor EVO756 in Chronic Inducible Urticaria During Late-Breaker at EADV 2025 Congress (PRNewswire) - "Clinical responses observed in 93 percent of patients at just four weeks in either FricTest Score or Pruritus-NRS, with improvements seen as early as week one. Favorable safety and tolerability profile observed....'We look forward to sharing top-line data from our ongoing Phase 2b studies of EVO756, with CSU data expected in the first half of 2026 and AD data expected in the second half of 2026'."

Late-breaking abstract • P2 data • Atopic Dermatitis • Chronic Spontaneous Urticaria • Urticaria

Phase 2b Study of EVO756 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Evommune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evommune Initiates Phase 2b Trial of its Oral MRGPRX2 Antagonist, EVO756, in Adults with Moderate to Severe Atopic Dermatitis (PRNewswire) - "Evommune...announced the enrollment of the first patient in a Phase 2b trial of EVO756....The Phase 2b trial of approximately 120 patients is a randomized, multi-center, double-blind, placebo-controlled, dose-ranging trial....Top-line data from the Phase 2b AD trial expected in second half of 2026."

P2b data • Trial status • Atopic Dermatitis

Phase 2b Study of EVO756 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Evommune, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology